Addressing US and European device testing requirements.
Medical device companies do not always realise that United States and European test requirements can be significantly different. Not addressing these differences can be costly when retesting or device redesign becomes necessary. This article discusses some of these differences and ways to help avoid repeat testing.
Donawa
Maria
M
Donawa Consulting, Rome, Italy. medonawa@donawa.com
D018795:Device Approval / Q000592:standards*; D019544:Equipment Failure Analysis / Q000592:standards*; D004864:Equipment and Supplies / Q000592:standards*; D005060:Europe; D033161:Government Regulation; D011358:Product Surveillance, Postmarketing / Q000592:standards*; D014481:United States